EP3558138A1 - Appareil pour former un passage dans un tissu et systèmes médicaux d'intervention associés - Google Patents

Appareil pour former un passage dans un tissu et systèmes médicaux d'intervention associés

Info

Publication number
EP3558138A1
EP3558138A1 EP17830064.6A EP17830064A EP3558138A1 EP 3558138 A1 EP3558138 A1 EP 3558138A1 EP 17830064 A EP17830064 A EP 17830064A EP 3558138 A1 EP3558138 A1 EP 3558138A1
Authority
EP
European Patent Office
Prior art keywords
dilator
lumen
shaft
outer diameter
distal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP17830064.6A
Other languages
German (de)
English (en)
Other versions
EP3558138B1 (fr
Inventor
Ronald A. Drake
Matthew D. Bonner
Trent M. Fischer
Brian P. COLIN
Lester O. Stener
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Inc
Original Assignee
Medtronic Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Inc filed Critical Medtronic Inc
Publication of EP3558138A1 publication Critical patent/EP3558138A1/fr
Application granted granted Critical
Publication of EP3558138B1 publication Critical patent/EP3558138B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • A61N1/057—Anchoring means; Means for fixing the head inside the heart
    • A61N1/0573—Anchoring means; Means for fixing the head inside the heart chacterised by means penetrating the heart tissue, e.g. helix needle or hook
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system
    • A61M2210/125—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37205—Microstimulators, e.g. implantable through a cannula

Definitions

  • the present invention pertains to forming a passageway through tissue in a body of a patient, for example, to position an interventional medical system.
  • Forming a passageway through tissue may be necessary in order to position an interventional medical system for delivery of therapy or diagnostics within an organ or the circulatory system of a patient.
  • the passageway is formed, via an apparatus that includes a needle, dilator, and introducer sheath, such as is known to those skilled in the art of interventional medical systems.
  • an apparatus that includes a needle, dilator, and introducer sheath, such as is known to those skilled in the art of interventional medical systems.
  • Embodiments of an apparatus disclosed herein for forming a passageway through tissue in a body of a patient, include a relatively flexible elongate shaft and a dilator mounted to a distal end thereof, wherein a first portion of the dilator has an increasing taper from a first outer diameter, at a proximal end of the dilator, to a larger second outer diameter, in proximity to a second portion of the dilator, and the second portion of the dilator has a decreasing taper from the first portion to a distal end of the dilator, and includes an external non-cutting thread formed along the decreasing taper.
  • the first portion of the dilator may also include an external non-cutting thread, which is formed along the increasing taper.
  • the dilator further includes a longitudinally extending lumen that extends proximally from a distal opening thereof, located at the distal end of the dilator, wherein the lumen of the dilator is in fluid communication with a lumen of the shaft so that the lumens of the shaft and dilator can provide a conduit for a means to pierce through the tissue, which is delivered out through the distal opening of the dilator lumen.
  • the apparatus includes a wire having a piercing distal tip as the means for piercing through the tissue, wherein the wire may include a flexible distal segment having a pre-formed J-shape.
  • the first portion of the apparatus dilator is configured to expand to, and contract from, the larger second outer diameter, for example, via another member of the apparatus.
  • the larger second outer diameter of the apparatus may be greater than or equal to an outer diameter of the introducer sheath, after the dilator is passed out from the lumen of the introducer sheath.
  • the other member of the apparatus may be a spreading member configured to slide within the first portion of the dilator, between the shaft and the first portion.
  • an interventional medical system includes a relatively compact implantable medical device, an introducer sheath, and any of the aforementioned embodiments of the apparatus, wherein the apparatus and the introducer sheath can be used to form a passageway through an interatrial septum of a patient's heart for subsequent delivery of the medical device therethrough, via the sheath.
  • the apparatus and the introducer sheath can be used to form a passageway through an interatrial septum of a patient's heart for subsequent delivery of the medical device therethrough, via the sheath.
  • Figure 1 is a schematic diagram showing a potential site for forming a
  • Figure 2A is a plan view of an exemplary relatively compact implantable medical device that may be included in systems of the present invention, according to some embodiments;
  • Figure 2B is a plan view, which includes a partial cross-section, of a portion of an exemplary interventional medical system
  • Figure 3A is a plan view of an apparatus for forming a passageway through tissue in a body of a patient, according to some embodiments
  • Figure 3B is a longitudinal cross-section view through a portion of the apparatus, according to some embodiments.
  • Figure 4A is an exploded perspective view of a dilator component, according to some embodiments.
  • Figure 4B is a longitudinal cross-section view of the component, according to some embodiments.
  • Figures 5A-D are schematics depicting a method for forming the passageway through the tissue
  • Figures 6A-B are perspective views of an alternate embodiment of an apparatus for forming a passageway through tissue in a body of a patient.
  • Figures 7A-B are cross-section views of the apparatus of Figures 6A-B and an introducer sheath, according to some embodiments of an interventional medical system.
  • Figure 1 is a schematic diagram showing a potential site S for forming a passageway through the interatrial septum so that a relatively compact implantable medical device, such as device 300 shown in Figure 2A, may be delivered to a cardiac implant site on a left side of a patient's heart.
  • Site S is preferably located along the septum in proximity to the Fossa Ovalis.
  • Figure 2A is a plan view of device 300, which is wholly contained within a relatively compact package, the entirety of which is configured for implant in close proximity to a pacing site.
  • Device 300 may be included in systems of the present invention, according to some embodiments, which also include a delivery tool that is described in the commonly assigned United States Patent Application US 2015/0094668.
  • FIG. 2A illustrates medical device 300 including a hermetically sealed housing 380, which extends from a proximal end 381 thereof to a distal end 382 thereof, and an electrode 320, which is mounted to housing distal end 382.
  • an electronic controller for example, a pulse generator and an associated power supply
  • electrode 320 is electrically coupled to the controller via a hermetically sealed feedthrough assembly (not shown) such as is known in the art.
  • Device housing 380 for example, formed from a biocompatible and biostable metal such as titanium, may be overlaid with an insulative layer, for example, medical grade polyurethane, parylene, or silicone, and, although not shown, device 300 may include another electrode, for example, formed by removing a portion of the insulative layer to expose the metallic surface of housing 380. The other electrode may function in conjunction with electrode 320 for bipolar pacing and sensing.
  • Device 300 further includes a fixation member, for example, formed by a plurality of super-elastic fingers 35 spaced apart from one another around a perimeter of housing distal end 382, which are configured to secure electrode 320 in intimate tissue contact at an implant site.
  • a fixation member for example, formed by a plurality of super-elastic fingers 35 spaced apart from one another around a perimeter of housing distal end 382, which are configured to secure electrode 320 in intimate tissue contact at an implant site.
  • fixation fingers 35 are integrally formed with one another, having been cut from Nitinol tubing, according to methods known in the art. After cutting the Nitinol tubing, fingers 35 may be shaped by bending and holding fingers 35 in the illustrated curvature while heat treating, according to methods known to those skilled in the art.
  • Fixation fingers 35 may be mounted to distal end 382 of device housing 380, for example, in a manner similar to that described for a fixation component 102 in a commonly assigned United States Patent Application 2012/0172690, which description is hereby incorporated by reference.
  • the super-elastic nature of Nitinol allows fingers 35 to elastically deform between a relaxed condition, which is shown, and an extended condition, in which a free end of each finger extends distally away from distal end 382 of device housing 380, for example, when device 300 is loaded into the
  • Figure 2B is a plan view, with a partial cross-section, of a portion of an exemplary interventional medical system, which includes device 300, delivery tool 100, and introducer sheath 200.
  • Figure 2B illustrates sheath 200 including an elongate tubular member 250 and a handle assembly 270 coupled to a proximal end 21 of member 250, wherein tubular member 250 defines a lumen 205, which is in fluid communication with a proximal port opening 273 of handle assembly 270, and is sized to allow passage of tool 100, with device 300 loaded therein, therethrough.
  • Figure 2B further illustrates a distal end 22 of tubular member 250 defining a distal-most opening 225 of lumen 205, which allows deployment of device 300 therethrough to an implant site.
  • device 300 may be directly loaded into sheath lumen 205 without the need for delivery tool 100.
  • an operator will need to pass sheath distal end 22 through tissue that forms the interatrial septum for example, at site S.
  • the system of Figure 2B may also include an apparatus 500 (described below in conjunction with Figures 3A-B), or an apparatus 600 (described below in conjunction with Figures 6A-B, 7A-B).
  • handle assembly 270 of introducer sheath 200 is shown including a control member 276 for an optional steering assembly of sheath 200.
  • the steering assembly may further include a pull band mounted on tubular member 250, in proximity to sheath distal end 22, and an elongate pull wire that extends along a length of tubular member 250, being coupled to the pull band and to control member 276.
  • Moving control member 276, per arrow D causes the pull wire to deflect outer tubular member 250, which may be useful in navigating the system.
  • tubular member 250 of sheath 200 may include a pre-formed curvature, in proximity to distal end 22, which is useful in navigating the system.
  • Figure 3A is a plan view of apparatus 500, according to some embodiments.
  • Figure 3B is a longitudinal cross-section view through a portion of apparatus 500, according to some embodiments.
  • Figures 3A-B illustrate apparatus 500 including a relatively flexible elongate shaft 510 and a relatively rigid dilator 540 mounted thereto, wherein a first portion 541 of dilator 540 extends around a distal end 512 of shaft 510, and a second portion 542 of dilator 540 extends from first portion 541 to a distal end 540D of dilator 540.
  • Dilator first portion 541 is shown having an increasing taper from a first outer diameter OD1 (e.g., about 0.12 inch), at a proximal end 540P of dilator 540, to a larger second outer diameter OD2 (e.g., about 0.3 inch), in proximity to second portion 542 dilator 540; and dilator second portion 542 is shown having a decreasing taper from second outer diameter OD2 to a smaller third outer diameter OD3 (e.g., about 0.04 inch), in proximity to distal end 540D of dilator 540.
  • a first outer diameter OD1 e.g., about 0.12 inch
  • second outer diameter OD2 e.g., about 0.3 inch
  • dilator second portion 542 is shown having a decreasing taper from second outer diameter OD2 to a smaller third outer diameter OD3 (e.g., about 0.04 inch), in proximity to distal end 540D of dilator 540.
  • Figure 3A further illustrates dilator second portion 542 including an external non-cutting thread 542T (e.g., having a radiused crest) formed along the decreasing taper.
  • a pitch p of thread 542T ( Figure 3B) may be about 0.125 inch in some embodiments.
  • larger second outer diameter OD2 of dilator 540 makes nearly a line-to-line fit of dilator 540 within lumen 205 of introducer sheath 200, so that apparatus 500, when passed through introducer sheath 200 and out through distal-most opening 225, for example, as described below in conjunction with Figures 5A-D, can form a passageway through the tissue of the largest possible size for sheath distal end 22 to pass through the tissue.
  • an operator by engaging dilator distal end 540D with the tissue, at an opening previously formed therethrough, and then rotating dilator 540 around a longitudinal axis thereof, causes dilator 540 to advance through the opening as a graduating diameter of non-cutting thread 542T (graduating from smaller third outer diameter OD3 to larger second outer diameter OD2) gradually increases the size of the opening to create, without undue trauma, the passageway for sheath distal end 22 to pass through the tissue.
  • the increasing taper of dilator first portion 541 facilitates retraction of dilator 540 back through the passageway, for example, since the tissue may have a relative toughness and elasticity to cause some contraction of the formed passageway.
  • the operator may simultaneously push sheath 200 to advance distal end 22 over dilator 540 and through the
  • dilator first portion 541 also includes an external non-cutting thread 541 T formed along the increasing taper, to further facilitate retraction of dilator 540 back through the passageway, via rotation thereof around the longitudinal axis.
  • shaft 510 and dilator 540 include lumens 501 , 504, respectively, which are in fluid communication with one another to provide a conduit for a means to pierce through the tissue, wherein the piercing forms the aforementioned opening that is a precursor to the passageway formed by dilator 540.
  • the means for piercing may be mechanical, as described below, or via radiofrequency energy, such as delivered through a wire like the Baylis Medical radiofrequency NRG® Transseptal Needle.
  • Figure 3B illustrates the means to pierce through the tissue being an elongate wire 570 that includes a piercing distal tip 572, which is slideably engaged within lumens 501 , 504.
  • Figure 3B further illustrates dilator lumen 504 having a nominal diameter that is smaller than that of shaft lumen 501 , for example, for a 'snugged fit around wire 570, just proximal to wire distal tip 572, that can provide enhanced back-up support for tip 572, when the operator advances tip 572 out through a distal opening 504O of lumen 504 to pierce through the tissue.
  • dilator lumen 504 is shown extending distally from a funnel-shaped entry 504E that increases an ease of passing wire distal tip 572 from shaft lumen 501 to dilator lumen 504.
  • Wire 570 after having been passed out though distal opening 504O, to pierce through the tissue, can form a rail to guide dilator 540 as the operator rotates dilator 540 to create the passageway through the tissue, as described below.
  • a proximal end of wire 570 extends out from a proximal hub 550 of apparatus 500, and has a tool 560 attached thereto, for example, to facilitate the operator's handling of wire 570.
  • Proximal hub 550 which is shown joined to a strain-relieved proximal end 51 1 of shaft 510, may be formed by a Tuohy-Borst type fitting with a side-port known to those skilled in the art.
  • Figure 3A further illustrates an insertion stop 557, for example, being formed by a polymer tube, fitted around the proximal end of wire 570, between hub 550 and tool 560, so that tool 560 will abut stop 557 to prevent wire 570 from sliding distally in lumens 501 , 504 before the operator is ready to pierce through the tissue.
  • insertion stop 557 may be tethered proximal end 51 1 of shaft 510, for example, to hub 550, so the operator cannot misplace it.
  • shaft 510 which may have a nominal outer diameter of about 0.12 inch and extend over a length of up to approximately 100 cm, from proximal end 51 1 to distal end 512, is formed by a stainless steel braid-reinforced medical grade polymer, for example, one or more appropriate grades of polyether block amide, which are arranged for decreasing stiffness from proximal end 51 1 to distal end 512 (e.g., including PEBAX® 3533, 4033, 6333, and 7233), and has a fluoropolymer (e.g., PTFE) or a polyether block amide material lining lumen 501 .
  • a stainless steel braid-reinforced medical grade polymer for example, one or more appropriate grades of polyether block amide, which are arranged for decreasing stiffness from proximal end 51 1 to distal end 512 (e.g., including PEBAX® 3533, 4033, 6333, and 7233), and has a fluoropolymer (e.g.,
  • a length of dilator 540, from proximal end 540P to distal end 540D may be up to about 1 inch (2.5 cm).
  • Dilator 540 for example, formed from a relatively rigid medical grade plastic that has a relatively low surface friction (e.g., polyoxymethylene or polyamide), may be over-molded onto shaft distal end 512, or machined or molded as a separate component 540-C, for example, as shown in Figures 4A-B, which is then secured to shaft distal end 512.
  • Figure 4A is an exploded perspective view of dilator component 540-C, according to some embodiments; and Figure 4B is a longitudinal cross-section view of component 540-C, according to some embodiments.
  • Figures 4A-B illustrate component 540-C including a mounting bore 54 that extends from proximal end 540P, along first portion 541 and into second portion 542, for example, over a length of about 0.5 inch.
  • Figure 4B further illustrates bore 54 extending to funnel-shaped entry 504E of lumen 504 so that bore 54 is in fluid communication therewith.
  • bore 54 is sized to allow insertion of shaft distal end 512 therein for mounting of dilator 540 thereto, so that shaft lumen 501 is in fluid communication with dilator lumen 504.
  • a hole 543 is shown formed through a sidewall of dilator first portion 541 , wherein hole 543 may extend from an outer surface of first portion 541 to bore 54, and then back through an opposing sidewall of first portion 541 , to the outer surface on the opposite side of bore 54.
  • hole 543 may serve as a pilot hole to form a hole (not shown) through shaft distal end 512 when inserted in bore 54, and then the aligned holes on either side of shaft lumen 501 may be filled with a material, for example, a medical grade adhesive, that provides a mechanical interlocking between dilator component 540- C and shaft 510.
  • dilator component 540-C further includes a pair of radiopaque markers 53R, each of which is fitted into a corresponding hole 543, according to some embodiments.
  • Dilator component 540-C may be machined from a relatively rigid medical grade thermoplastic (e.g., Delrin®, a polyoxymethylene copolymer), and markers 53R may be tubular bands of 90/10 Platinum/lridium.
  • Figures 5A-D are schematics depicting a method for forming a passageway 530 through tissue that forms a septal wall SW, for example, the aforementioned interatrial septal wall.
  • Figure 5A illustrates apparatus 500 having been advanced by an operator into a body of a patient, for example, through sheath lumen 205, until dilator distal end 540D is adjacent to wall SW.
  • Figure 5A further illustrates piercing distal tip 572 of wire 570 having been advanced by the operator out though dilator lumen distal opening 504O ( Figure 3B) to pierce tissue of septal wall SW. Then, with reference to Figure 5B, the operator may further advance wire 570 so that tip 572 pierces through wall SW to create an opening
  • Figure 5B illustrates a significantly flexible distal segment 570D of wire 570 having a pre-formed J-shape and extending proximally from piercing distal tip 572.
  • flexible distal segment 570D is deformable to extend lengthwise within lumens 501 , 504 ( Figure 3B), and then flops over, after tip 572 pierces through wall SW, to prevent tip 572 from piercing into any other tissue.
  • wire 570 may be a 0.035 inch J Tip Fixed core angiographic guide wire, such as is known to those skilled in the art, and piercing tip 572 (e.g., formed from a medical grade stainless steel hypo-tube) is attached thereto, for example, by crimping and/or welding methods known in the art.
  • piercing tip 572 e.g., formed from a medical grade stainless steel hypo-tube
  • the operator can enlarge the opening to form passageway 530 ( Figure 5C) by rotating shaft 510 and, thus, dilator 540, per arrow R1 , which advances dilator 540 through the opening and over wire 570.
  • Figures 5A-C further illustrate dilator 540 including radiopaque markers 53R, for example, as described above in conjunction with Figure 4A, which allow the operator to visualize, via fluoroscopy, the rotation of dilator 540.
  • the graduated non-cutting thread 542T of dilator creates passageway 530 without undue trauma to septal wall SW.
  • the aforementioned nearly line-to-line fit of dilator 540 within sheath lumen 205, as illustrated in Figure 5A, provides for the largest possible size of passageway 530 for sheath distal end 22 to pass through.
  • the tissue of septal wall SW may contract somewhat in the wake of dilator 540 due to the aforementioned relative toughness and elasticity of the tissue.
  • the operator may retract dilator 540 through passageway 530 while pushing sheath 200, per arrow P, through passageway 530.
  • the operator may find retraction of dilator 540 difficult by simply pulling apparatus 500, so, embodiments of dilator 540 that include the optional first portion non-cutting thread 541 T, as shown, allow the operator to rotate apparatus 500, per arrow R2, to drive a more effective retraction of dilator 540 back through passageway 530.
  • the operator may deflect sheath 200, for example, via the optional steering assembly described above, for example, to orient distal-most opening 225 of sheath 200 toward the left ventricle for a subsequent deployment of device 300, for example, via tool 100 ( Figure 2B) advanced through sheath 200.
  • an apparatus for forming a passageway through tissue in a body of a patient includes a dilator configured to expand and contract, so that, when expanded, the dilator can form a larger passageway for sheath distal end 22, for example, like a dilator 640 of apparatus 600, which is shown in the perspective views of Figures 6A-B.
  • Figure 6A illustrates dilator 640 mounted to a relatively flexible elongate shaft 610, and the above-described wire 570 extending out from a distal opening 604O of a lumen 604 of dilator ( Figures 7A-B).
  • Dilator 640 extends from a proximal end 640P to a distal end 640D thereof, and includes a first portion 641 and a second portion 642, wherein second portion 642 has a decreasing taper from first portion 641 to distal end 640D and includes a non-cutting thread 642T (e.g. , having a radiused crest) formed along the decreasing taper, similar to second portion 542 of dilator 540.
  • a pitch of thread 642T may be about 0.125 inch, in some embodiments, and outer diameter OD3 ( Figure 7B) of dilator 640, in proximity to distal end 640D, may be about 0.04 inch.
  • dilator second portion 642 is relatively rigid to advance through an opening in tissue, for example, having been formed by wire 570, and to gradually increase the size of the opening with the graduated thread 642T, which creates, without undue trauma, the
  • lumen 604 of dilator 640 is in fluid communication with a lumen 601 of shaft 610 ( Figures 7A-B) to provide a conduit for a means to pierce through the tissue, for example, wire 570.
  • Figure 6A further illustrates apparatus 600 including a spreading member
  • spreading member 630 which extends around shaft 610 in sliding engagement therewith, for the purpose of expanding dilator first portion 641 , as shown in Figure 6B and 7B, and described in detail below.
  • spreading member 630 is shown including an elongate tube 637 and a spreading head 631 mounted thereto.
  • an operator can slide spreading member 630 distally, by pushing tube 637, per arrow S, to move spreader head 631 into a gap 614 that extends between dilator first portion 641 and shaft 610, for example, as illustrated in the cross-section views of Figures 7A-B.
  • dilator first portion 641 is expandable by means of a plurality of flaps 641 F that extend proximally from second portion 642 to free ends thereof at proximal end 640P of dilator 640.
  • Figure 6A shows flaps 641 F being spaced apart from one another, around a circumferential perimeter of first portion 641 , by a plurality of slots 641 S.
  • Each flap 641 F includes an internal ridge 641 R, so that when the operator slides spreader head 631 into gap 614, between dilator first portion 641 and shaft 610, each of a plurality of engagement surfaces 63 of head 631 confronts a corresponding ridge 641 R to push the corresponding flap 641 F of dilator first portion 641 outward, for example, to larger second outer diameter OD2, as shown in Figure 6B and Figure 7B.
  • Figures 6A-B further illustrate spreader head 631 including a plurality of longitudinally extending lobes 603, which are spaced apart from one another around a circumferential perimeter of head 631 , and are sized to fit within slots 641 S of dilator first portion 631 , for example, to enhance a rigidity of dilator first portion 641 , as dilator 640 is rotated, per arrow R, to advance through the opening and form the passageway.
  • Figures 7A-B are cross-section views of the apparatus 600 and introducer sheath 200, according to some embodiments of an interventional medical system.
  • Figure 7A illustrates spreader head 63 located between first portion flaps 641 F and shaft 610, but proximal to ridges 641 R, so that dilator first portion 641 is approximately isodiametric, for example, at first outer diameter OD1 , and fits within lumen 205 of introducer sheath 200 for passage therethrough.
  • Figure 7B illustrates spreader head 631 having been slid in between dilator first portion 641 and shaft 610 so that engagement surfaces 63 confront ridges 641 R and expand dilator first portion 641 .
  • the expanded dilator first portion 641 has an increasing taper from first outer diameter OD1 , in proximity to dilator proximal end 640P, to larger second outer diameter OD2, in proximity to dilator second portion 642.
  • larger second outer diameter OD2 for dilator 640 is greater than or equal to an outer diameter of introducer sheath 200, at distal end 22, in proximity to distal opening 225 of sheath lumen 205.
  • the operator may advance apparatus 600, with dilator first portion 641 contracted from second outer diameter OD2, through lumen 205 of introducer sheath 200 until dilator distal end 640D is adjacent to tissue in a patient's body, for example, septal wall SW described above. Then, after the operator forms an opening through the tissue, for example, by advancing wire 570 through apparatus lumens 601 , 604 and out distal opening 604O to pierce through the tissue, the operator may rotate apparatus 600 to begin advancing dilator 640 through the opening, either before or after sliding head 631 of spreading member 630 into dilator first portion 641 , per arrow S ( Figure 7B), to expand first portion 641 to second outer diameter OD2.
  • the graduated thread 642T of dilator second portion 642 gradually increases the size of the opening as dilator 640 moves therethrough, and the larger second outer diameter OD2 of dilator first portion 641 makes the passageway, formed from the opening, large enough for the operator to pass sheath distal end 22 therethrough in the wake of dilator 640.
  • apparatus shaft 610 which may have a nominal outer diameter of about 0.12 inch and extend over a length of up to approximately 100 cm, is formed by a stainless steel braid-reinforced medical grade polymer, for example, one or more appropriate grades of polyether block amide, which are arranged for decreasing stiffness, from a proximal end to a distal end thereof (e.g., including PEBAX® 3533, 4033, 6333, and 7233), and has a fluoropolymer (e.g., PTFE) or a polyether block amide material lining lumen 601 .
  • a stainless steel braid-reinforced medical grade polymer for example, one or more appropriate grades of polyether block amide, which are arranged for decreasing stiffness, from a proximal end to a distal end thereof (e.g., including PEBAX® 3533, 4033, 6333, and 7233), and has a fluoropolymer (e.g., PTFE) or a polyether block
  • a length of dilator 640, from proximal end 640P to distal end 640D may be up to about 1 .5 inch (3.8 cm).
  • Dilator 640 for example, formed from a relatively rigid medical grade plastic that has a relatively low surface friction (e.g.,
  • Spreading member tube 637 may be relatively flexible, for example, being formed from PEBAX® 5533, or relatively stiff, for example, being formed from a suitable medical grade polyimide. If the latter, tube 637, when spreader head 631 is slid within dilator first portion 641 , can provide some additional rigidity helpful to advance dilator 640 through the opening to form passageway, and/or, in some cases, to straighten an optional preformed curvature of sheath tubular member 250.

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  • Veterinary Medicine (AREA)
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  • Biophysics (AREA)
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  • Surgical Instruments (AREA)
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Abstract

La présente invention concerne un appareil (500) pour former un passage à travers un tissu comprenant un dilatateur (540) monté sur un arbre (510), le dilatateur (540) comprenant une première partie (541), qui a une conicité croissante d'un premier diamètre externe (OD1) à un deuxième diamètre externe plus élevé (OD2), et une deuxième partie (542), qui a une conicité décroissante de la première partie à une extrémité distale (540D) du dilatateur, et qui comprend un fil de non-coupe externe (542T) formé le long de la conicité décroissante. Les lumières (504, 501) du dilatateur (540) et de l'arbre (510) constituent un conduit pour qu'un moyen (570) perce le tissu, le moyen étant un fil allongé qui comprend une pointe de perçage (572). Dans certains cas, la première partie de dilatateur peut se dilater vers, et se contracter depuis, le deuxième diamètre externe plus élevé, l'appareil pouvant comprendre un élément d'étalement configuré pour coulisser entre l'arbre et la première partie. L'appareil est destiné à être inclus dans un système avec une gaine d'introduction.
EP17830064.6A 2016-12-21 2017-12-19 Systèmes médicaux interventionnels comprenant un appareil pour former un passage dans un tissu Active EP3558138B1 (fr)

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US15/387,224 US10448971B2 (en) 2016-12-21 2016-12-21 Apparatus for forming a passageway in tissue and associated interventional medical systems
PCT/US2017/067314 WO2018118918A1 (fr) 2016-12-21 2017-12-19 Appareil pour former un passage dans un tissu et systèmes médicaux d'intervention associés

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US20180168687A1 (en) 2018-06-21
CN110072474A (zh) 2019-07-30
US10448971B2 (en) 2019-10-22
EP3558138B1 (fr) 2022-08-10
US11617600B2 (en) 2023-04-04
CN110072474B (zh) 2022-09-23
US20200046407A1 (en) 2020-02-13
WO2018118918A1 (fr) 2018-06-28

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